Job Description

Job Overview


We are seeking an experienced Pharmacovigilance professional with strong expertise across drug development, registration, and post-approval phases for New Chemical Entities (NCEs) . The role will be responsible for end-to-end safety activities, regulatory compliance, signal management, and benefit-risk assessment across global programs.


Key Responsibilities


  • Lead and manage PV safety activities for assigned New Chemical Entities (NCEs)
  • Ensure timely completion of safety deliverables in compliance with global regulations and internal SOPs
  • Define safety data acquisition strategy, methodology, and analytical approach
  • Review and provide input on study protocols, safety management plans, and safety reporting requirements
  • Review adverse events (AEs) and serious adverse events (SAEs) from clinical studies
  • Review safety data (tables, figures, listings), Clinical Study Reports (CSRs), and Investigator Brochures (IBs)
  • Support development of safety-related data collection forms for clinical trials
  • Oversee signal management activities, including literature surveillance, documentation, and tracking
  • Plan and review periodic aggregate safety reports including DSURs, PSURs, PBRERs, ADCOs , and line listings
  • Manage responses to regulatory authority queries (USFDA, Health Canada, PRAC RFIs) related to PV
  • Review and support labelling justification documents from a PV perspective
  • Contribute to risk management strategy and development of Risk Management Plans (RMPs)
  • Support new drug applications and other regulatory filings
  • Collaborate with cross-functional teams: Clinical, Regulatory Affairs, Medical Writing, Labelling, QPPV, and CROs
  • Act as interface between global project leads, CROs, and internal teams
  • Participate in Safety Governance activities
  • Support internal audits and regulatory inspections


Qualifications & Skills


  • MD/MBBS or Doctorate in Life Sciences / Pharmacy / Medicine
  • 7-8 years of relevant experience in Pharmacovigilance / Drug Safety
  • Strong exposure to clinical and post-marketing PV activities
  • Hands-on experience with aggregate reports, signal management, and regulatory interactions
  • Good understanding of global PV regulations (ICH, EMA, USFDA)
  • Excellent communication, stakeholder management, and documentation skills

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